An IEC 62304 Checklist tracks compliance across the software development lifecycle for medical devices. To build an effective XLS tool, you must categorize requirements by Software Safety Class (A, B, or C) to determine which activities are mandatory. 🛠️ Core XLS Structure
29, 14.2, "Vulnerability management", Security, "Process to identify, track and remediate security vulnerabilities", "Vulnerability log, patch management process", "Vulnerabilities assessed and remediated", Not Started, Security Team, , , High, Iec 62304 Checklist Xls
| Column A | Column B | |----------|----------| | Safety Class | A, B, C (based on possible harm) | | Clause Ref | IEC 62304 clause number | | Required | Yes / No / Conditional | | Verification | Not started / In progress / Done / N/A | An IEC 62304 Checklist tracks compliance across the
Verification: Perform unit verification, integration testing, and system testing. Download or build the XLS structure provided above